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By Alex Manie May 07, 2023 35

Children exposed to hydroxychloroquine during their mothers' pregnancy are at higher risk of serious birth defects

An American study showed a risk of malformation in children exposed during pregnancy to hydroxychloroquine multiplied by 1.33 compared to those who were not exposed to it. Following these results evaluated at European level, the summary of product characteristics and the leaflet for Plaquenil (hydroxychloroquine) is being updated.

This study , which compared 2045 pregnancies exposed to 19,080 pregnancies not exposed to hydroxychloroquine in the first trimester, showed an increase in malformation risk from a daily dose greater than or equal to 400 mg. These are malformations classified as serious , without it being possible to highlight a particular type of malformation. Furthermore, although the study does not seem to show any risk for doses below 400 mg, the data remains too limited to date to exclude this risk.

In France, Plaquenil is the only medicine containing hydroxychloroquine. It is indicated in adults in the treatment of rheumatoid arthritis, subacute or discoid lupus erythematosus, in the adjunctive treatment or prevention of relapses of systemic lupus as well as in the prevention of lucites.

Information for patients treated with hydroxychloroquine (Plaquenil)

  • If you are of childbearing age and do not plan to become pregnant , contraception is recommended.
  • If you are planning to become pregnant , talk to your doctor who will work with you to determine the treatment appropriate to your medical situation.
  • If you are pregnant , talk to your doctor who will determine with you whether it is necessary to continue treatment. Do not stop taking hydroxychloroquine without discussing it with your doctor, as your illness may worsen and have serious consequences for you and your child.
  • Increased self-awareness: Mindfulness meditation can help individuals.

If treatment is continued, reinforced obstetric monitoring of your fetus must be put in place. After birth, medical monitoring of your child, particularly his vision, will also be necessary given the adverse effects of hydroxychloroquine.

Information for prescribers

women of childbearing age :
  • Take into account the risk of malformation in any prescription of hydroxychloroquine. Inform your patients and remind them of the importance, if they are planning to become pregnant, of talking to you about it in order to adapt the treatment with them.
  • Recommend the use of a method of contraception.
During pregnancy:
  • Avoid prescribing hydroxychloroquine unless the benefit to the mother clearly outweighs the potential risks to the child.
  • If treatment is continued, the lowest effective dose should be used and careful obstetric monitoring should be implemented throughout the pregnancy.

After the birth of a child exposed during the long term of pregnancy , we also remind you that the profile of adverse effects of hydroxychloroquine, particularly ophthalmological, must be taken into account when monitoring the child.